AMH for the Identification of PCOM in PCOS Diagnosis

Polycystic Ovary Syndrome Clinical Trial

— HARMONIA  

Official title:

Human Anti-MülleRian Hormone for Diagnosis of PCOS Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05527353
• Other study ID #: 49/2019
• Status: Recruiting
• Start date: May 13, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2022
• Source: Oulu University Hospital
• Contact: Terhi T Piltonen, Professor
• Phone: +358 8 3153051
• Email: terhi.piltonen[@]oulu.fi
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to validate the anti-müllerian hormone (AMH) cut-off established and validated in the APHRODITE study, for the determination of PCOM as part of the diagnosis of PCOS, using the Elecsys AMH Plus immunoassay.

Description:

The study participants will be women born July 1985-Dec 1987 in Northern Finland; the study partially links to the Northern Finland Birth Cohort 1986. Female subjects included in this cohort will be invited to participate in the study with the aim to enroll up to 1800 subjects. Each enrolled subject will have one study visit, where the clinical data required for assessing their PCOS status will be recorded, including a gynecological examination by transvaginal ultrasound to determine polycystic ovarian morphology (PCOM) status (antral follicle count and ovarian volume). Study subjects will also have blood drawn for serum collection, where hormonal parameters relevant for PCOS will be measured. The collected serum will also be used to measure the AMH levels using the Roche Elecsys AMH test.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1800
• Est. completion date: December 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 32 Years to 37 Years

Eligibility

Inclusion Criteria:

• Female

• Born July 1985-Dec 1987 in Northern Finland

• Signed informed consent regarding ROCHE collaboration

Exclusion Criteria:

• Unwilling to undergo gynecological examination including transvaginal ultrasound (TVUS)

• Unwilling to have blood drawn

• Pregnancy

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome

Locations

Country	Name	City	State
Finland	Oulu University Hospital	Oulu

Sponsors (2)

Lead Sponsor	Collaborator
Oulu University Hospital	Roche Diagnostics

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The validation of the performance of the AMH cut-off, established in the APHRODITE study, to diagnose PCOM in the context of PCOS diagnosis.	The performance (sensitivity and specificity) of the AMH cut-off will be calculated by comparing the AMH values to the PCOM status of the subjects based on the TVUS findings (AFC & Ovarian volume).	Baseline
Secondary	Prevalence of PCOS in general population	PCOS is diagnosed based on the Rotterdam Criteria with the presence of at least two of the following symptoms: 1. Polycystic ovarian morphology by trans-vaginal ultrasound (>=20 follicles in either ovary or ovarian volume >= 10 mL), 2. Hyperandrogenism, either clinical or biochemical (testosterone/free androgen index) and 3. oligo-amenorrhea (< 8 menstruations/year).	Baseline